BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RING-HANDLED CHANNEL BRUSH

    MDR report key: 12106534 · Received July 2, 2021

    Report

    Report Number
    12106534
    Event Type
    Malfunction
    Date Received
    July 2, 2021
    Date of Event
    June 29, 2021
    Report Date
    June 29, 2021
    Manufacturer
    CYGNUS MEDICAL L.L.C.
    Product Code
    MNL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RECEIVED THE ITEM THAT IS USED IN THE STERILE PROCESSING DEPARTMENT (SPD) THAT WAS RUSTY. THE SPD SUPERVISOR REPORTED IT, CONSIDERED IT A DEFECT. MANUFACTURER RESPONSE FOR RING-HANDLED CHANNEL BRUSH, RING-HANDLED CHANNEL BRUSH (PER SITE REPORTER): REQUESTING RGA AND MAILER TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008463 RING-HANDLED CHANNEL BRUSH ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE MNL CYGNUS MEDICAL L.L.C. 91-212 031860-1-120191217

    Patients

    Seq Age Sex Outcome Treatment
    1